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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter

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 Class 2 Device Recall Baxtersee related information
Date Initiated by FirmDecember 12, 2002
Date PostedJanuary 23, 2003
Recall Status1 Terminated 3 on June 29, 2004
Recall NumberZ-0458-03
Recall Event ID 25210
510(K)NumberK003245 
Product Classification Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
Product100 U/mL Heparin Lock Flush Solution USP; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
Code Information all lots within expiration date of the following pre-filled syringes: Code 2K6049: 3 mL in 12 mL syringe Code 2K6050: 5 mL in 12 mL syringe Code 2K6058: 5 mL in 12 mL syringe w/cannula
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
Rt 120 & Wilson Rd
Round Lake IL 60073
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall
Sterility questioned
FDA Determined
Cause 2
Other
ActionRecalled by letter dated 12/12/02. Customers were informed of the compromised sterility of all lots of the listed products within expiration date, and were requested to destroy all lot numbers of the identified product codes. Baxter will issue their customers credit for the product destroyed.
Quantity in Commerce727,560 syringes
DistributionNationwide, Canada, Honduras, Indonesia, Israel
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FOZ
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